FDA's Oncologic Drugs Advisory Committee to Hold First Meeting Under New Commissioner

The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) is set to convene its inaugural meeting under the leadership of new agency commissioner Marty Makary, M.D. The two-day meeting, scheduled for May 20 and 21, will spotlight several high-profile cancer drugs from major pharmaceutical companies, including Johnson & Johnson, Pfizer, Roche, and UroGen Pharma.

Key Drug Applications Under Review

Roche's Columvi for DLBCL

Roche is seeking to move Columvi up in the treatment sequence for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in transplant-ineligible patients. The application is based on the phase 3 Starglo trial, which demonstrated a 41% reduction in the risk of death when combining Columvi with the chemotherapy regimen GemOx, compared to Rituxan and GemOx. However, an exploratory analysis revealed that the survival benefit was primarily driven by patients outside the U.S. and Europe, raising questions about its efficacy in these regions.

Johnson & Johnson's Darzalex Faspro for Smoldering Multiple Myeloma

J&J is seeking to expand the use of Darzalex Faspro to high-risk smoldering multiple myeloma, a condition that can develop into full-blown myeloma. The phase 3 Aquila trial showed that patients receiving Darzalex Faspro experienced a 51% lower risk of progression or death compared to simple monitoring. However, the drug also demonstrated a higher rate of grade 3 or 4 treatment-emergent adverse events.

Industry Implications and FDA Transition

The upcoming ODAC meeting holds particular significance as it marks the first such gathering under the new FDA leadership. With Richard Pazdur, M.D., now the sole remaining FDA center director from the previous administration, the pharmaceutical industry will be closely monitoring for signs of policy consistency.

The recent mass layoffs at the FDA have raised concerns about potential delays in drug reviews, despite critical drug reviewers being spared from the downsizing. Additionally, the almost complete makeover of senior FDA leadership under Commissioner Makary has led to speculation about possible changes in drug policy.

As the industry awaits further clarity on the FDA's direction under new leadership, Dr. Pazdur remains optimistic about the future of cancer drug development. At a recent award acceptance speech, he stated, "I firmly believe that the next 25 years will bring even more transformative advances than the last," highlighting the ongoing progress in precision oncology and cancer treatment.